Catalog Number 1011707-28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Stenosis (2263)
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Event Date 02/04/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.The reported patient effects of angina and stenosis are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll) everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The xience prime 2.5 x 23 referenced in the report is being filed under a separate medwatch report number.
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Event Description
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It was reported that on (b)(6) 2014, the patient underwent a coronary stenting procedure with implantation of a 3.0 x 38 mm xience prime stent in the proximal left anterior descending artery, a 2.5 x 23 mm xience prime stent in the first obtuse marginal artery and a 2.5 x 28 mm xience prime stent in the distal circumflex artery.On (b)(6) 2015, the patient began to experience angina and was re-hospitalized on (b)(6) 2015.A revascularization procedure was performed, on (b)(6) 2015, to treat in-stent restenosis at the distal circumflex artery, within 5 mm of the previously implanted stent and the event resolved on (b)(6) 2015.On (b)(6) 2016, the patient began to experience angina and was re-hospitalized on (b)(6) 2016.Revascularization was performed on (b)(6) 2016 to treat in-stent restenosis at the 1st obtuse marginal artery, within 5 mm of the previously implanted stent and the event resolved on (b)(6) 2016.On (b)(6) 2016, the patient began to experience angina and was rehospitalized on (b)(6) 2016.A revascularization procedure was performed, with stent implantation at the 1st obtuse marginal artery, within 5 mm of the previously implanted stent.The event resolved on (b)(6) 2016.No additional information was provided.
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Search Alerts/Recalls
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